Catalyst Files Patent Infringement Suit Against Jacobus and PantherRx

Rare Daily Staff

Catalyst Pharmaceutical said it filed patent infringement lawsuits against both Jacobus Pharmaceuticals and PantherRx following a legal setback at the end of September when a federal judge granted the U.S. Food and Drug Administration summary judgement in a related case.

The company filed a lawsuit in the U.S. District Court for New Jersey against Jacobus Pharmaceuticals and a lawsuit in the U.S. District Court for the Western District of Pennsylvania against PantherRx Rare. The suits allege the companies infringed a patent that Catalyst exclusively licensed that covers certain methods for treating disease using amifampridine, including Catalyst’s drug Firdapse (amifampridine) for the rare autoimmune disorder known as Lambert-Eaton Myasthenic Syndrome (LEMS) in which the body attacks the junction between nerves and muscles.

Jacobus and PantherRx sell and market Ruzurgi (amifampridine). The lawsuits allege that Ruzurgi infringes the patent when administered in accordance with its product labeling. The lawsuit seeks damages and injunctive relief to prevent further marketing of Ruzurgi in violation of Catalyst’s patent rights.

“Catalyst has invested significant resources in neuromuscular drug discovery and in building an intellectual property portfolio that aids in the discovery and development of drugs for the treatment of rare neurodegenerative diseases that are without a safe and effective FDA approved therapy,” said Patrick McEnany, chairman and CEO of Catalyst. “We intend to diligently and vigorously protect our patent rights for the benefit of our company and our stockholders and prevent infringing use by others. Catalyst remains confident in its patent portfolio and has filed several additional patent applications claiming priority from the ‘893 patent to enhance the protection of the Firdapse patent estate.”

 In June 2019, Catalyst filed a lawsuit against the FDA demanding it vacate its approval of Jacobus’ drug Ruzurgi for the treatment of LEMS in pediatric patients. Catalyst’s drug Firdapse was approved in late 2018 to treat adults with LEMS.

The lawsuit was part of an ongoing controversy over the price of amifampridine, which had been available for free from Jacobus under an FDA compassionate use program. That ended when the FDA approved Catalyst’s Firdapse in late November 2018. Catalyst then proceeded to price its drug at an annual list price of $375,000 along with a patient assistance program. The price sparked public outrage.

Only a few months after the Catalyst approval, the FDA approved Jacobus’ LEMS drug for use in pediatric patients based on data from studies of adult LEMS patients. Jacobus announced that it was pricing its LEMS pill at just under half the cost of a similar dosage of Catalyst’s pill.

Catalyst argued the approval of Jacobus’ Ruzurgi was an illegal regulatory workaround of its seven years of exclusivity for Firdapse. While a drug approved for pediatric use can be prescribed off-label for adults, a drug approved for adult use cannot be prescribed for pediatric patients under the Orphan Drug Act as well as other provisions.

But a district judge found against Catalyst’s interpretation of the Orphan Drug Act that the relevant statutory language in the Orphan Drug Act was ambiguous, and adopted FDA’s interpretation rather than Catalyst’s.  The District Judge also rejected Catalyst’s argument that the approved labeling for Ruzurgi is false and misleading.

As a result of the judge’s decision, Ruzurgi remains approved for the treatment of pediatric LEMS patients in the United States.

Photo: Patrick McEnany, chairman and CEO of Catalyst Pharmaceuticals